Search Results

The Doppler FHR Detector (Model BF-500D+ and BF-560) is intended to detect fetal heart beats, display fetal heart rate, and play the fetal heart sound in patients with singleton pregnancies after 12 weeks of gestation. The device is intended to be used by health care professionals in a hospital, clinic, community, and home setting.

The Fetal Doppler is a hand-held device for non-invasive measurement and display of the fetal heart beat utilizing Doppler ultrasound. The device consists of two main components, the main unit and probe. The main unit consists of the main board, power module, battery, speaker, and liquid crystal display(LCD) screen. The wired probe consists of the transducer and includes two angled semi-circle ultrasonic crystals, one for transmission and one for reception. The ultrasonic signal is continuously transmitted at one frequency.

The difference between BF-500D+ and BF-560 are shown as below:

• BF-500D+ is powered by a 9V rechargeable Ni-MH battery, and adapter is packaged with the unit; BF-560 is powered by three pieces of 1.5V AA alkaline disposable batteries.
• BF-500D+ will display Fetal heart rate, sound volume, and battery indicator; BF-560 will also display the selected working frequency besides in addition to the features of the BF-500D+.
• the two models have different probe shapes.

This 510(k) clearance letter pertains to a Doppler FHR Detector, a device intended to detect fetal heartbeats, display fetal heart rate, and play the fetal heart sound. The document describes non-clinical performance testing conducted to demonstrate substantial equivalence to a predicate device.

It's important to note that this document does not describe a study involving human subjects or AI-assisted diagnostic read-outs. Therefore, sections related to multi-reader multi-case studies, expert adjudication for ground truth for test sets, and the impact of AI assistance on human readers are not applicable.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a structured, quantitative table for all performance aspects. Instead, it demonstrates compliance with recognized standards and successful completion of various tests. The tables in the original document ("Table 6-1: Comparison between the predicate device BF-500B and the subject device BF-500D+" and "Table 6-2: Comparison between the predicate device BF-500B and the subject device BF-560") provide a comparison of technical characteristics and indicate "Same" or "Different" for each item, implying that similarity or acceptable differences were the internal criteria for many parameters.

For the performance tests explicitly mentioned in section 7, the reported device performance is that the device "complied with requirements" or "successfully passed all aspects of the testing." I will create a table summarizing the performance parameters that have a quantifiable criterion or a clear pass/fail outcome from the provided text.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set:
  • Biocompatibility: Not explicitly stated, but "Patient contacting materials were subjected to testing."
  • Electrical safety and EMC: Not explicitly stated.
  • Ultrasound and Acoustic Testing: Not explicitly stated.
  • Software Verification and Validation Testing: Not explicitly stated.
  • Use Life Testing: n=3 samples for each device model (BF-500D+ and BF-560).
• Data Provenance: The studies described are non-clinical bench tests. There is no mention of data from human subjects or country of origin for such data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This was a non-clinical performance study. No human ground truth was established by experts for these tests.

4. Adjudication Method for the Test Set

Not applicable. As this was a non-clinical performance study, there was no expert adjudication process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC comparative effectiveness study was not done. This document describes non-clinical performance testing of a medical device, not a study evaluating human reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This device is a Doppler FHR Detector, which is a hardware device for detecting fetal heart rates, displaying them, and playing sounds. While it involves software, it's not an "algorithm-only" or AI-driven diagnostic device in the sense of image analysis or complex pattern recognition. The software is for device control and display of measured physiological parameters. The non-clinical performance testing implicitly evaluates the "standalone" performance of the device's measurement capabilities.

7. The Type of Ground Truth Used

For the non-clinical tests described:

• Biocompatibility, Electrical safety, EMC, Ultrasound and Acoustic Testing: Ground truth is established by the requirements and methodologies of the respective international standards (e.g., ISO 10993-1, IEC 60601-1, IEC 60601-2-37, IEC 62359). These standards define the acceptable limits and procedures.
• Software Verification and Validation: Ground truth is against the software requirements specification and FDA guidance for software in medical devices.
• Use Life Testing: Ground truth is provided by a fetal heart rate simulator for performance evaluation under worst-case operational scenarios, and the expected durability of the physical components (e.g., batteries, buttons).

8. The Sample Size for the Training Set

Not applicable. This is a non-AI, non-machine learning device. There is no concept of a "training set" in the context of these non-clinical performance studies.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

Ask a specific question about this device

The Ultrasonic Fetal Doppler (Model M520, M521, M523) is intended to detect and display fetal heart rate, and used by health care professionals in a hospital, clinic, community, and home setting for singleton pregnancies after 16 weeks gestation.

Not Found

The provided text is a 510(k) clearance letter from the FDA for an "Ultrasonic Fetal Doppler." This document primarily focuses on regulatory approval and does not contain specific information about the acceptance criteria, study details, or performance metrics of the device as typically found in clinical validation studies.

Therefore, I cannot extract the requested information regarding:

• A table of acceptance criteria and the reported device performance
• Sample size used for the test set and data provenance
• Number of experts used to establish ground truth and their qualifications
• Adjudication method
• Multi-reader multi-case (MRMC) comparative effectiveness study results or effect size
• Standalone performance details
• Type of ground truth used
• Sample size for the training set
• How the ground truth for the training set was established

The document states the device's intended use: "to detect and display fetal heart rate, and used by health care professionals in a hospital, clinic, community, and home setting for singleton pregnancies after 16 weeks gestation." However, it does not provide the technical validation data that would be used to establish equivalence and meet performance criteria.

Ask a specific question about this device

The Pocket Fetal Doppler (Models CONTEC 10D, CONTEC 10E and CONTEC10F) is used to detect the fetal heart rate. The device should be used by health care professionals including nurses, midwives, and specialized technicians in the hospital, clinic, community and home. The device is intended for use at or after 12 weeks gestation.

The Pocket Fetal Doppler is a hand-held fetal Doppler used for non-invasive measurement and numerical display of the fetal heart rate (FHR) utilizing pulsed-wave Doppler ultrasound. The Pocket Fetal Doppler includes three models: CONTEC10E and CONTEC10E and CONTEC10F. All models have four components: upper shell, display and probe. The material for probe cap and shell is ABS. The device contains an ultrasonic signal transmitter and receiver, analog signals processing unit, FHR calculating unit, and LCD display control unit. The device is used to detect the fetal heart rate. The device should be used by health care professionals including nurses, midwives, and specialized technicians in hospital, clinic, community and home. This device can detect a fetal heart rate value at or after twelve weeks gestation.

The CONTEC10D is powered by a 3.7V lithium battery, the ultrasonic signal is continuously transmitted at a frequency of 2.5MHz.

The CONTEC10E and CONTEC10F is powered by two 1.5V batteries (AA LR6), the ultrasonic signal is continuously transmitted at a frequency of 2.5MHz.

The FDA 510(k) summary for the Pocket Fetal Doppler (CONTEC 10D, 10E, 10F) does not contain the level of detail typically found in a clinical study report for device acceptance criteria and performance, especially for AI/ML-based devices. This is a traditional medical device (fetal Doppler) and not an AI/ML device, hence some of the requested information (like number of experts for ground truth, adjudication methods, MRMC studies, or training set details) is not applicable or provided in this document.

However, based on the provided text, here's an attempt to extract the relevant information regarding performance and acceptance, and clarify what is not applicable or available:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are primarily based on its ability to accurately measure fetal heart rate (FHR) within specified ranges and its compliance with relevant electrical safety, EMC, and performance standards.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

The document describes non-clinical testing to verify design specifications and compliance with standards. It does not mention a "test set" in the context of patient data or clinical trials with a specific sample size. The performance metrics (FHR range, resolution, accuracy) are likely derived from bench testing using simulators or controlled inputs, and not from a dataset of patient recordings.

• Sample Size: Not specified as it's non-clinical, likely involves a series of tests on manufactured units.
• Data Provenance: Not applicable in the context of patient data. The tests are performed on the device itself.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. This is a hardware device measuring a physiological parameter. The "ground truth" for its performance is established by reference to calibrated measurement equipment and standardized test protocols, not by expert human interpretation of data.

4. Adjudication Method for the Test Set:

Not applicable. There is no human interpretation or "test set" for adjudication, as it's a non-clinical device performance study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, an MRMC study was not done. This type of study is relevant for AI/ML diagnostic aids where the impact on human reader performance is evaluated. This device is a direct measurement tool for FHR, not an interpretive aid.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done:

Yes, the performance characteristics (FHR measuring range, resolution, accuracy, acoustic output) are essentially standalone performance metrics of the device as an instrument, independent of human interpretation during a diagnostic process. The stated performance data (e.g., FHR accuracy ±2 BPM) represents the device's inherent capability.

7. The Type of Ground Truth Used:

The "ground truth" for the non-clinical performance tests is based on technical specifications and adherence to international and national standards. For example:

• FHR accuracy would be verified against a precisely known or simulated fetal heart rate signal.
• Acoustic output would be measured using specialized acoustic measurement equipment.
• Biocompatibility is determined by laboratory testing against ISO 10993 standards.

8. The Sample Size for the Training Set:

Not applicable. This device does not employ machine learning or AI that would require a "training set" of data.

9. How the Ground Truth for the Training Set was Established:

Not applicable, as there is no training set for this traditional medical device.

Ask a specific question about this device

The Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL) is used to detect the fetal heart rate. The device should be used by health care professionals including nurses, midwives, and specialized technicians in the hospital, clinic, community and home. The device is intended for use at or after 12 weeks gestation.

The Pocket Fetal Doppler is a hand-held FHR detection device, it is used for non-invasive measurement and display of the fetal heart rate (FHR) utilizing Doppler ultrasound. The Pocket Fetal Doppler consists of two models (CONTEC10C, CONTEC10CL). Both models have two hand-held components, a main unit and a probe. The device contains components of ultrasonic signal transmitter and receiver, analog signals processing unit, FHR calculating unit, and LCD display control unit.

The provided text is a 510(k) Premarket Notification for a Pocket Fetal Doppler. It details the device's characteristics, indications for use, comparison to a predicate device, and results of non-clinical testing. However, it does not include information about acceptance criteria for performance metrics (beyond resolution and accuracy values), NOR does it describe a study involving human readers or experts to prove the device meets these criteria.

Therefore, many of the requested points cannot be extracted from the provided text.

Based on the information available:

1. A table of acceptance criteria and the reported device performance

The document provides performance specifications for the device and a predicate, but doesn't explicitly state "acceptance criteria" in a pass/fail sense in this section. It lists the device's performance characteristics.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not provided in the document. The testing described is non-clinical performance and safety testing, not human use studies with a test set of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. No human experts were used for a test set in the context of device performance claims based on this document. The testing focused on device specifications and compliance with standards.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. No test set involving human interpretation/adjudication was described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a direct measurement tool (Fetal Doppler) and does not involve AI assistance or human interpretation/improvement studies as described in the document.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This largely describes the type of testing performed. The device's performance (FHR range, resolution, accuracy) was tested in a standalone capacity against specifications, not as part of an algorithm's performance in image interpretation. The testing validated the device's ability to measure FHR.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the device performance metrics (FHR range, resolution, accuracy), the "ground truth" would be established by calibrated measurement equipment and reference standards typically used in medical device testing, not biological ground truth like pathology or outcomes.

8. The sample size for the training set

Not applicable. This document does not describe the development or testing of an AI algorithm with training data.

9. How the ground truth for the training set was established

Not applicable. No training set for an AI algorithm was described.

Ask a specific question about this device

The Fetal Doppler is used to detect the fetal heart rate. The device should be used by health care professionals including nurses, midwives, and specialized technicians in hospital, clinic, community and home. The device is intended for use at or after 16 weeks gestation.

The Fetal Doppler, model TK-T802CR, is a hand-held, battery powered audio Doppler device used for detecting fetal heart beats and sounds. The Fetal Doppler is used for non-invasive detection and display of the fetal heart rate (FHR) utilizing Doppler ultrasound. It has two hand-held components, a main unit and a probe. The main unit consists of the main board, power module, battery, speaker, and LCD screen. The probe consists of the ultrasonic transducers for transmission and for signal reception. The ultrasonic signal is continuously transmitted at a frequency of 2.0, 2.5, or 3.0 MHz, depending on the probe settings selected.

This document describes the premarket notification (510(k)) for the Shenzhen Taikang Medical Equipment Co., Ltd. Fetal Doppler. The FDA has determined the device is substantially equivalent to legally marketed predicate devices.

Acceptance Criteria and Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Vcomin Technology Limited Company Fetal Doppler, Model: FD-200D). The performance data provided is largely in the form of testing against applicable standards and showing similarity/equivalence to the predicate device, rather than explicit acceptance criteria and reported performance in a quantitative table for each functional aspect of the device in a clinical study.

However, based on the provided text, we can infer some key performance aspects and their reported outcomes:

Study Details:

The provided text from the 510(k) summary does not describe a clinical study with human subjects, a test set, expert readers, or ground truth establishment in the manner typically associated with AI/ML device evaluations. This submission is for a traditional medical device (Fetal Doppler) where substantial equivalence is demonstrated through engineering and performance testing against standards, and comparison to a predicate device.

Therefore, the following points are not applicable or not detailed in this specific 510(k) summary, as it's not a submission for an AI/ML-based device:

2. Sample size used for the test set and the data provenance: Not applicable in the context of a clinical test set for AI/ML. The performance testing was likely conducted in a lab environment using appropriate phantoms, simulators, or controlled setups as per the referenced standards (e.g., IEC 60601-2-37 for ultrasonic medical diagnostic equipment).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a Fetal Doppler's accuracy would be established through calibrated instruments or reference measurements, not expert consensus on images.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this is not an MRMC study. The device is a diagnostic tool, not an AI assistance system for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a "standalone" hardware device, not an algorithm. Its performance is evaluated intrinsically.
7. The type of ground truth used: For FHR accuracy, the ground truth would be precise, known heart rate simulations from equipment or calibrated reference measurements. For biocompatibility, it's lab test results comparing to established biological responses. For electrical safety, it's compliance with specified measurement limits.
8. The sample size for the training set: Not applicable, as this is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.

In summary, for this Fetal Doppler (K211940), substantial equivalence was demonstrated primarily through:

• Comparison to a predicate device (K182526) showing sameness in intended use, design, mode of action, and core FHR specifications.
• Non-clinical performance testing against recognized international and national standards for biocompatibility (ISO 10993), electrical safety and electromagnetic compatibility (IEC 60601 series), battery safety (IEC 62133), software verification (FDA guidance), use-life, FHR accuracy (IEC 60601-2-37), and acoustic output (NEMA UD 2 and FDA guidance).

The documentation asserts that any differences in technological characteristics (like acoustic output) do not raise new questions of safety and effectiveness, thus supporting the substantial equivalence determination.

Ask a specific question about this device

Fetal Doppler is intended to detect fetal heart rate, and play the fetal heart sound. Fetal Doppler is indicated for use by health care professionals in hospital, clinic, community and home for singleton pregnancies after 12 weeks gestation.

Fetal Doppler is intended to detect fetal heart beats, display fetal heart rate, and play the fetal heart sound. Fetal Doppler is indicated for use by used by health care professionals in hospital, clinic, community and home for singleton pregnancies after 12 weeks gestation. It is comprised of an ultrasonic signal transmitter and receiver, analog signal processing unit, FHR calculating unit, and LCD/TFT display control unit. It has audio output and can be connected with headphones or to a recorder with audio input. The Fetal Doppler is powered by a standard 1.5 V DC alkaline battery.

This document seems to be a 510(k) summary for a Fetal Doppler device, not a study evaluating a device's performance against specific acceptance criteria in the way a clinical trial or algorithm validation study would. Therefore, much of the requested information regarding acceptance criteria for an AI/ML algorithm or a comparative effectiveness study is not available in the provided text.

The document instead focuses on demonstrating substantial equivalence to a predicate device through conformity with standards and basic performance tests.

Here's a breakdown of what is available and what is not:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table with "acceptance criteria" and "reported device performance" in the context of an AI/ML algorithm's effectiveness. Instead, it outlines performance data provided to support substantial equivalence, primarily focusing on safety and basic operational characteristics.

Here's a summary of the performance testing conducted, which might be interpreted as meeting certain "acceptance criteria" for basic functionality:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The performance tests mentioned (biocompatibility, software V&V, electrical safety, use/battery life, acoustic output) are engineering tests, not typically clinical studies involving patient data or test sets in the context of an AI/ML algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable/not provided. The document describes testing of a medical device's physical and software components, not an AI/ML algorithm requiring expert ground truth for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable/not provided. As above, this document does not describe an AI/ML algorithm validation study that would involve expert adjudication of a test set.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable/not provided. This document is for a Fetal Doppler, which is not an AI-assisted diagnostic device. Therefore, no MRMC study or AI assistance evaluation was conducted or reported.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable/not provided. The Fetal Doppler is a standalone device; the question about "algorithm only" performance applies to AI/ML devices, which this is not. The device itself performs the function of detecting and displaying FHR.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not applicable/not provided. The "ground truth" for a Fetal Doppler would be the actual fetal heart rate, which is derived directly from its acoustic processing, not from expert consensus or pathology in a diagnostic sense. The accuracy of the FHR measurement is stated as ±2BPM.

8. The sample size for the training set

This information is not applicable/not provided. This device is not an AI/ML algorithm that requires a "training set."

9. How the ground truth for the training set was established

This information is not applicable/not provided. This device is not an AI/ML algorithm that requires a "training set" with ground truth.

Ask a specific question about this device

HeraBEAT™ US is intended to detect fetal heart beats, display fetal heart rate, and play the fetal heart sound. HeraBEAT™ US is indicated for use by medical professionals in clinical or home care settings for singleton pregnancies from 12 weeks gestation.

HeraBEAT™ US is a hand-held, battery powered audio Doppler device integrated with 2MHz probe, used for detecting and displaying the fetal heart rate (FHR) and FHR sound. The device uses an optical sensor to distinguish between the FHR and the maternal heart rate (MHR) to eliminate "crosstalk" in the FHR display.

HeraBEAT™ US includes the following components:

• The handheld HeraBEAT™ US device that incorporates an ultrasound transducer, rechargeable battery, and internal microcontroller and Bluetooth Low Energy (BLE) chip for wireless data transfer from the HeraBEAT™ US device to the user's smartphone.
• The HeraBEAT™ application, which is downloaded from an app store to the user's smartphone. The HeraBEAT™ application is used to communicate with the HeraBEAT™ US device using wireless BLE. It controls the operation of the device and receives the FHR values for numerical display to the user. It plays the FHR sound and stores the FHR values in a history log.

HeraBEAT™US is supplied with a battery charger (power supply), two tubes of commercially available Aquasonic 100 Ultrasound Transmission Gel (cleared under K802146), carry case and User Manual.

The HeraBEAT™ US fetal ultrasonic monitor is intended to detect fetal heart beats, display fetal heart rate, and play the fetal heart sound. It is indicated for use by medical professionals in clinical or home care settings for singleton pregnancies from 12 weeks gestation.

Here's an analysis of its acceptance criteria and the supporting study information:

1. Acceptance Criteria and Reported Device Performance

The document implicitly defines acceptance criteria through its comparison to the predicate device, MD800. The key performance metric is Fetal Heart Rate (FHR) measurement accuracy.

Note: The HeraBEAT™ US has a wider FHR measuring range (240 bpm) compared to the predicate (210 bpm), which suggests an improvement or at least equivalent capability. The accuracy and resolution are identical to the predicate.

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not specify a sample size for a clinical test set for FHR measurement accuracy. It mentions "Bench Performance Testing" where "Clinical measurement accuracy was conducted per the acoustic output measurement methodology as recommended in the FDA guidance document." This suggests the accuracy was validated using simulated signals or known standards in a lab environment, not necessarily a study with a test set of actual patients.

Therefore, details on data provenance (country of origin, retrospective/prospective) and the type of ground truth are not applicable as there is no described clinical test set for FHR accuracy.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the document as there is no described clinical test set with human-established ground truth for FHR measurement. The accuracy was assessed against acoustic output measurement methodologies, not expert interpretation of fetal heart sounds/rates from patients.

4. Adjudication Method

This information is not provided in the document. As there is no described clinical test set involving human interpretation and ground truth establishment, adjudication methods are not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

There is no mention of an MRMC comparative effectiveness study in the provided document. The submission focuses on substantial equivalence based on technical characteristics and bench testing.

6. Standalone Performance Study

The document describes "Bench Performance Testing" where "Clinical measurement accuracy was conducted per the acoustic output measurement methodology as recommended in the FDA guidance document 'Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers,' dated September 9, 2008." This indicates that the device's accuracy in measuring FHR was assessed using a controlled, standalone method, likely with calibrated equipment or simulated signals, to verify its technical specifications. However, this is distinct from a clinical standalone study involving human patients.

7. Type of Ground Truth Used

For the "Bench Performance Testing" of FHR measurement accuracy, the ground truth was established by:

• Acoustic output measurement methodology per FDA guidance: This implies the use of validated standards and equipment to measure the acoustic output and resulting FHR determination, rather than expert consensus, pathology, or outcomes data from patients.

8. Sample Size for the Training Set

The document does not provide any information regarding a training set for the HeraBEAT™ US device. Given that it's a fixed-function fetal doppler, it's unlikely to rely on typical machine learning training sets in the same way an AI-powered diagnostic image analysis tool would. Its performance is based on established signal processing and measurement principles inherent in the hardware and software design.

9. How Ground Truth for the Training Set Was Established

This information is not applicable as no training set is mentioned for the device.

Ask a specific question about this device

The DMX Handheld Doppler: Indicated for use by qualified healthcare practitioners in primary, acute and community healthcare environments, for the non-invasive assessment of vascular blood flow to assist in diagnosis. The SRX Handheld Doppler: Indicated for use by qualified healthcare practitioners in primary, acute and community healthcare environments, for the assessment of fetal heart rate to assist in diagnosis.

The DMX Doppler provides the clinician with the ability to perform vascular investigations. It is powered from two internal replaceable AA format 1.5 volt alkaline or 1.2 volt NiMH rechargeable batteries. The DMX hand unit is used with a Doppler or Arterial Photoplethysmography (APPG) probe, selected to suit the nature of the investigation to be performed. The device includes a colour liquid crystal display and three soft keys for user input. Doppler audio sounds are reproduced by the integral loudspeaker; the audio level can be adjusted by two buttons. Doppler Mode: The probes emit low energy ultrasonic waves into the body which are reflected back into the probe. The reflected ultrasonic waves contain information about the blood flow, which can be heard as audio sounds from the loudspeaker and waveforms presented on the display. There is a range of compatible Doppler probes; the choice of probe is determined by the type of vascular assessment being performed and depth of vessel. APPG Mode: The APPG sensor emits low energy infra-red light into the body, some of which is reflected by blood within the tissue back into the sensor. The variation of this reflected light is related to the blood volume within the tissue. The APPG probe is used with an inflatable cuff and sphygmomanometer gauge to measure toe / finger blood pressures. Dopplex Reporter 5 (DR5) Software Package: The DR5 software is a medical device data system (MDDS) and is an optional accessory to the dopplex® DMX bidirectional Doppler. It can display bidirectional velocity/time waveforms obtained from various vessels. Data can be archived and a printout can be obtained for patients notes. The DR5 is not a standalone medical device – it can only be used with the DMX Doppler to display, archive and print Doppler waveforms and PPG pressures produced by the DMX. The SRX Doppler range is intended to be used by qualified healthcare practitioners for the detection and presentation of the fetal heart rate to assist in the assessment of fetal well-being during pregnancy. Each model is powered from two internal replaceable AA format 1.5 volt alkaline or 1.2 volt NiMH rechargeable batteries. The SRX hand unit is used with a choice of either a 2MHz (OP2XS) or 3MHz (OP3XS) obstetric Doppler probe. The SR2 and SR3 have fixed probes (2MHz and 3MHz respectively). All models include a colour liquid crystal display and three soft keys for user input. Doppler audio sounds are reproduced by the integral loudspeaker; the audio level can be adjusted by two buttons. The probes emit low energy ultrasonic waves into the body some of which are reflected back into the probe. The reflected ultrasonic waves contain information about the fetal heart, which can be heard as audio sounds from the loudspeaker and heart rate values presented on the display.

This document describes the Huntleigh Healthcare Ltd DMX/SRX Handheld Doppler and Probes, and its substantial equivalence to predicate devices. It focuses on engineering and performance verification, rather than clinical studies with acceptance criteria in the context of device performance metrics like sensitivity or specificity.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of acceptance criteria for specific performance metrics (e.g., accuracy, sensitivity, specificity) of the DMX/SRX Handheld Doppler, especially in comparison to clinical outcomes. Instead, it details various engineering and regulatory compliance testing.

The document states that "The data detailed within this submission demonstrates that the device is as safe and effective and performs as well as the predicate devices identified in this summary, which are currently marketed for the same intended use." This implies that the acceptance criteria are met if the new device demonstrates similar performance and safety characteristics as the legally marketed predicate devices through the conducted verification and validation tests.

Below is a table summarizing the types of testing performed, which serve as the basis for demonstrating equivalence and meeting "acceptance criteria" in a broad sense for a 510(k) submission:

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify a "test set" in the context of clinical data or patient samples. The testing described (biocompatibility, software, hardware, safety, EMC, environmental) refers to engineering and quality assurance testing of the physical device and its software. Therefore, sample sizes for patient data or data provenance are not applicable here.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

Not applicable. The submission focuses on substantial equivalence through engineering and regulatory compliance testing, not clinical performance against a ground truth established by experts.

4. Adjudication Method for the Test Set:

Not applicable. There is no mention of a test set requiring adjudication in the clinical sense.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study is not mentioned as having been performed. The submission is for a handheld Doppler device and focuses on demonstrating substantial equivalence to predicate devices through technical and safety performance, not on AI-assisted interpretation or improvement for human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. The DMX/SRX Handheld Doppler is a medical device that provides direct physiological measurements (blood flow audio, waveforms, fetal heart rate, APPG pressures for DMX). While it has software and processing capabilities, it is not an "algorithm only" device in the sense of AI software for diagnostic interpretation. Its "performance" is inherently tied to human use (e.g., correctly positioning the probe, interpreting the audio/visual output).

7. Type of Ground Truth Used:

For the specified tests, the "ground truth" would be established by:

• Biocompatibility: Standardized test methods and controls as defined by ISO 10993-1.
• Software Performance: Requirements specifications and expected software behavior.
• Electronic Hardware/Mechanical Performance: Design specifications, engineering drawings, and functional requirements.
• Electrical Safety/EMC: Relevant IEC standards and their specified limits.
• Environmental Performance: Specified operating and storage conditions and their associated performance limits.

There is no mention of pathology, expert consensus, or outcomes data being used as ground truth for these engineering verification tests.

8. Sample Size for the Training Set:

Not applicable. The DMX/SRX Handheld Doppler is not explicitly described as employing trainable machine learning algorithms. The testing relates to the device's inherent design and functionality, not a model trained on a dataset.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as no training set for machine learning is indicated.

Ask a specific question about this device

The device is used to detect the fetal heart rate. The device should be used by health care professionals including nurses, midwives, and specialized technicians in hospital, clinic, community and home.

The 510(k) covers four series of Fetal Doppler devices, including FD-200, FD-231, FD-591, and FD-640. Each series contains two models, and four series consists of a total of eight individual models (FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B, and FD-591D). The subject devices are used for non-invasive measurement and display of the fetal heart rate (FHR) utilizing Doppler ultrasound. All models have two hand-held components, a main unit and a probe. The main unit consists of the main board, power module, battery, speaker, and LED screen. The probe consists of the ultrasonic transducers for transmission and one for signal reception. The ultrasonic signal is continuously transmitted at a frequency of 2.0. 2.5, or 3.0 MHz, depending on the probe selected. The reflected continuous signal is received, and detected Doppler shift is presented to the user. These devices are intended for use at or after 12 weeks' gestation.

The provided text is a 510(k) summary for a Fetal Doppler device. It describes the device, its intended use, and substantial equivalence to a predicate device, but it does not contain a detailed study proving the device meets specific acceptance criteria based on clinical performance with a test set, ground truth, or expert involvement.

The summary focuses on non-clinical performance testing and substantial equivalence.

Here's a breakdown of the requested information based on the provided document, highlighting what is not available:

1. Table of acceptance criteria and the reported device performance

Note: The document states that the FHR measuring range of the subject device is 50-210 bpm, while the predicate device is 50-230 bpm. This is a difference, but the document concludes it "does not raise different questions of safety and effectiveness."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not available. The document describes non-clinical performance testing, not a clinical study involving a test set of patient data to evaluate algorithmic performance. The "Use-life testing" involved evaluating "pressing-key performance and FHR measurement accuracy" under "simulated repeated use conditions," but this is not a clinical test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not available. No clinical test set with expert-established ground truth is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not available. No clinical test set with adjudication is mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable / Not available. This device is a Fetal Doppler, which directly measures FHR. It is not an AI-assisted diagnostic tool that would typically involve human readers interpreting AI output.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not applicable / Not available. This is a hardware device for FHR detection. The "Performance" section lists device specifications for FHR measuring range, resolution, and accuracy, which are standalone device performance metrics. However, these are not the result of an "algorithm only" study in the context of AI/ML, but rather the intrinsic performance of the sensing and processing hardware.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• For the FHR accuracy claim (±2 bpm), the ground truth would typically be established by a highly accurate reference standard for heart rate measurement. The document implies this was evaluated during "Use-life testing" under "simulated repeated use conditions," but does not explicitly state the ground truth methodology. It would likely involve a calibrated signal generator or a highly precise alternative FHR measurement system. It does not involve expert consensus, pathology, or outcomes data.

8. The sample size for the training set

• Not applicable. This device is a Fetal Doppler, not an AI/ML device that requires a "training set" for an algorithm.

9. How the ground truth for the training set was established

• Not applicable. As above, there is no mention of a training set as this is not an AI/ML device.

Ask a specific question about this device

The Fetal Doppler is intended to detect fetal heart beats, display fetal heart rate, and play the fetal heart sound from early gestation. The device should only be used by a trained medical professional in a clinical setting and is not intended for operated by the patient at home.

The subject device (model FD88) is a hand-held device for non-invasive measurement and display of the fetal heart rate (FHR) utilizing Dopler ultrasound. It includes two major components: main unit and probe. The main unit consists of the main board, power module, battery, speaker, and LCD screen. The main unit is supplied by a rechargeable 3.7V/500mAh Li-ion battery. The wired probe contains two angled semi-circle ultrasonic crystals, one for transmission and the other for reception. The ultrasonic signal is continuously transmitted (at a frequency of 2.5 MHz), received and presented to the user as numerical display. This device is intended to be used after 12 weeks gestation for singleton by a trained health professional in a clinical setting.

The provided text describes the acceptance criteria and the study conducted for the Fetal Doppler, Model FD88 (K182710).

Here's the information broken down as requested:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state "acceptance criteria" for the Fetal Doppler's performance. Instead, it states that the device's "Performance is Same as the predicate device," and then lists the predicate device's performance specifications. Therefore, the predicate device's performance can be inferred as the "acceptance criteria" for substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a separate "test set" for performance evaluation in terms of patient data or clinical trials. The performance data is derived from non-clinical performance testing. The document lists several types of non-clinical tests conducted, such as biocompatibility, cleaning/disinfection validation, software verification/validation, electrical safety, EMC, battery performance, ultrasound testing, acoustic output testing, and use-life testing. These tests evaluate the device's technical specifications and safety rather than its diagnostic accuracy on a patient population.

Therefore:

• Sample size for the test set: Not applicable in the context of patient data for diagnostic accuracy. The "test set" consists of the physical device units undergoing various engineering and safety tests.
• Data provenance: Not explicitly stated as being from a specific country or retrospective/prospective clinical data for a "test set." The studies are non-clinical performance testing conducted in a laboratory setting.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The provided document details non-clinical performance and safety testing, not diagnostic accuracy requiring expert panel review or ground truth establishment from patient data. The "ground truth" for these engineering tests would be established by reference standards, regulatory requirements (e.g., ISO, IEC), and established engineering principles.

4. Adjudication Method for the Test Set

Not applicable, as this was not a clinical study involving human readers or interpretation of diagnostic output that would require adjudication. The testing involved objective measurements against established standards and design specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. The document describes non-clinical performance testing, not a comparative effectiveness study involving human readers.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, in the sense that the device's technical performance (e.g., FHR measurement range, resolution, accuracy, acoustic output) was evaluated in isolation, independent of a human operator, to ensure it met its specifications and safety standards. This is inherent in the "non-clinical performance testing" described. The device's ability to detect and display FHR is presumed to be the "algorithm's" core function.

7. The Type of Ground Truth Used

The ground truth for the non-clinical performance testing was based on:

• Reference standards and regulatory guidelines: e.g., ISO, IEC, FDA guidance documents for biocompatibility, electrical safety, EMC, ultrasound testing, and acoustic output.
• Design specifications: The device's internal design specifications for FHR measurement range, resolution, and accuracy, which were stated as being "Same as the predicate device."
• Functionality validation: Demonstrating that features like battery life, operation time, recharging, and status indicator functions met "all design specifications."

8. The Sample Size for the Training Set

Not applicable. This is not a study involving machine learning or artificial intelligence where a "training set" would be used to develop an algorithm’s performance. The Fetal Doppler is a medical device based on established Doppler ultrasound technology, not a learning-based system.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for this device.

Ask a specific question about this device